Article 1A Union authorisation is granted to Novadan ApS for the biocidal product family "Teat disinfectants biocidal product family of Novadan" with authorisation number EU-0019757-0000.The Union authorisation is valid from 7 April 2019 until 31 March 2029.The Union authorisation is subject to compliance with the summary of the biocidal product characteristics set out in the Annex.

Article 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 13 March 2019.For the CommissionThe PresidentJean-Claude JunckerANNEXSummary of product characteristics for a biocidal product familyTeat disinfectants biocidal product family of NovadanProduct type 3 — Veterinary hygiene (Disinfectants)Authorisation number: EU-0019757-0000R4BP asset number: EU-0019757-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name

Name	Teat disinfectants biocidal product family of Novadan

1.2.Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

1.3.Authorisation holder

Name and address of the authorisation holder	Name	Novadan ApS
	Address	Platinvej 21, 6000 Kolding, Denmark
Authorisation number	EU-0019757-0000
R4BP asset number	EU-0019757-0000
Date of the authorisation	7 April 2019
Expiry date of the authorisation	31 March 2029

1.4.Manufacturer(s) of the biocidal products

Name of manufacturer	Novadan ApS
Address of manufacturer	Platinvej 21, 6000 Kolding Denmark
Location of manufacturing sites	Platinvej 21, 6000 Kolding Denmark

1.5.Manufacturer(s) of the active substance(s)

Active substance	Polyvinylpyrrolidone iodine
Name of manufacturer	Marcus Research Laboratory, Inc.
Address of manufacturer	Delmar Blvd., 63103-1789 Saint Louis, Missouri United States
Location of manufacturing sites	Delmar Blvd., 63103-1789 Saint Louis, Missouri United States

Active substance	Iodine
Name of manufacturer	Cosayach Nitratos S.A.
Address of manufacturer	Hnos Amunátegui 178, 8320000 Santiago Chile
Location of manufacturing sites	S.C.M. Cosayach Cala Cala, 1180000 Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	ACF Minera S.A.
Address of manufacturer	San Martin No 499, 11 00000 Iquique Chile
Location of manufacturing sites	Lagunas mine, 1180000 Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	Sociedad Quimica y Minera (SQM) S.A.
Address of manufacturer	Los Militares 4290, Piso 4, Las Condes, 8320000 Santiago Chile
Location of manufacturing sites	Nueva Victoria plant, 5090000 Pedro de Valdivia plant Chile

2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		0,714	3,57
Iodine		Active Substance	7553-56-2	231-442-4	0,15	0,75

2.2.Type(s) of formulation

Formulation(s)

SL — Soluble concentrateAL — Any other liquidEW — Emulsion, oil in water

PART IISECOND INFORMATION LEVEL — META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.Meta SPC 1 identifier

Identifier

meta-SPC 1

1.2.Suffix to the authorisation number

Number

1-1

1.3.Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 1 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		3,57	3,57
Iodine		Active Substance	7553-56-2	231-442-4	0,75	0,75

2.2.Type(s) of formulation of the meta SPC 1

Formulation(s)

SL — Soluble concentrate

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	May be corrosive to metals.Harmful to aquatic life with long lasting effects.Safety data sheet available on request.
Precautionary statements	Keep out of reach of children.Keep only in original packaging.Avoid release to the environment.Absorb spillage to prevent material damage.Dispose of contents in accordance with local/regional/national/international regulation.Dispose of container in accordance with local/regional/national/international regulation.

4.AUTHORISED USE(S) OF THE META SPC 14.1.Use description

Table 1. Use # 1: Post-milking manual dipping (concentrate)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual dipping (concentrate)Fill the reservoir with the diluted concentrate and screw the dip cup on top.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed.After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.
Application rate(s) and frequency	Dilution: 20 %Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.1.1.Use-specific instructions for useSee general directions for use.4.1.2.Use-specific risk mitigation measuresSee general directions for use.4.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.4.2.Use description

Table 2. Use # 2 – Post-milking, manual spraying, trigger sprayer (concentrate)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual spraying, trigger sprayer (concentrate)Fill the reservoir with the diluted concentrate and screw the top of the trigger sprayer on it.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, spray the disinfectant on the teats using the trigger sprayer making sure that each teat is covered with the disinfectant. Top up the reservoir with fresh disinfectant as needed.After disinfection, empty the reservoir and clean reservoir and sprayer by rinsing with water.
Application rate(s) and frequency	Dilution: 20 %Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.2.1.Use-specific instructions for useSee general directions for use.4.2.2.Use-specific risk mitigation measuresWear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) when applying the product by manual spraying.4.2.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.4.3.Use description

Table 3. Use # 3 – Post-milking manual spraying using an electronic sprayer (concentrate)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual spraying, electronic sprayer (concentrate)Open a can containing the diluted concentrate and insert the suction tube of the electronic sprayer.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, spray the disinfectant on the teats using the electronic sprayer making sure that each teat is covered with the disinfectant. Replace the empty can by a new can as needed. After disinfection, put the suction tube system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.
Application rate(s) and frequency	Dilution: 20 %Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.3.1.Use-specific instructions for useSee general directions for use.4.3.2.Use-specific risk mitigation measuresWear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) when applying the product by manual spraying.4.3.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.3.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.3.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.4.4.Use description

Table 4. Use # 4 – Post-milking automated dipping (concentrate)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated dipping (concentrate)Open a can containing the diluted concentrate and insert the suction tube of the automated dipping-system.Before milking clean teats carefully by automatic procedure or manually.After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air. In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air. Afterwards, the milking system is ready for the next milking event. The whole process is automated.
Application rate(s) and frequency	Dilution: 20 %Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.4.1.Use-specific instructions for useSee general directions for use.4.4.2.Use-specific risk mitigation measuresSee general directions for use.4.4.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.4.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.4.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.4.5.Use description

Table 5. Use # 5 – Post-milking automated spraying by robot (concentrate)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated spraying by robot (concentrate)Open a can containing the diluted concentrate and insert the suction tube of the robotic milking device.The teats are cleaned by robot with automatic brushes. After robotic milking, 2-4 ml of the disinfectant is sprayed automatically onto teats from a cluster arm. Rinsing of the sprayer is automatic.
Application rate(s) and frequency	Dilution: 20 %Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.5.1.Use-specific instructions for useSee general directions for use.4.5.2.Use-specific risk mitigation measuresSee general directions for use.4.5.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.5.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.5.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. OF THE META SPC 15.1.Instructions for useDilute the concentrated product by decanting or pumping. Fill the reservoir with the diluted concentrate and screw the dip cup on top. The concentrate is to be diluted 1:4 The concentrated products in meta-SPC 1 contain 0,89 % total iodine and are diluted 1:4 to an in-use solution containing 0,178 % total iodine. This corresponds to a 20 % (w/w) dilution.The use of a dosing pump for filling the product into the application equipment is recommended.The products must be brought to temperatures above 20 °C before use.To ensure sufficient contact time, care should be taken that the product is not removed after application. Leave the product on the teats and keep the animals standing for at least five minutes after treatment for post-milking disinfection.5.2.Risk mitigation measuresIn case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentDescription of first aid measuresGeneral: Remove affected person from source of contamination.After inhalation: Remove person to fresh air and keep comfortable for breathing. Get medical attention if any discomfort continues.After skin contact: Rinse with water. Remove contaminated clothing and shoes. Seek medical advice if any skin reaction/or discomfort occurs.After eye contact: Immediately rinse with water (at least 15 minutes). Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if any discomfort continues.After ingestion: Contact poison treatment specialist immediately if symptoms occur and/or in case of mouth contact with large quantities. Do not give fluids or induce vomiting in case of impaired consciousness; place in recovery position and seek medical advice immediately.If medical advice is needed, have product container or label at hand.Environmental emergency measuresPrevent run-off from entering drains, sewers or waterwaysInform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air)Dike to collect larger liquid spillsContain and/or absorb spill with inert material, then place in closed and suitable container for disposal according to regulationsDo not place spilled materials back into the original container5.4.Instructions for safe disposal of the product and its packagingMethod of disposal: Dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.Empty containers are rinsed with plenty of water and disposed to normal or commercial waste.The paper towels used for the cleaning of teats are disposed in the normal rubbish.Product classified as hazardous waste: NoPackaging classified as hazardous waste: NoEWC waste code: EWC: 0706 wastes from the MFSU of fats, grease, soaps, detergents, disinfectants and cosmeticsOther information: When handling waste, consideration should be made to the safety precautions applying to handling of the product. Waste code applies to product remnants in pure form.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageMentioned in the SDS: Keep in original container. Store the product away from direct sunlight in opaque containers. Keep separate from food, feedstuffs, fertilisers and other sensitive material. Store above freezing.Storage temperature: 0 – 30 °CShelf-life: 24 months.6.OTHER INFORMATIONpH range of meta-SPC 1: 4-57.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 17.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	Nova DipIO DipUdder Des 1:4 JodEwodipJodopax vetFova Dip 1:4Tehotippi
Authorisation number	EU-0019757-0001 1-1
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		3,57
Iodine		Active Substance	7553-56-2	231-442-4	0,75

META SPC 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.Meta SPC 2 identifier

Identifier

meta-SPC 2

1.2.Suffix to the authorisation number

Number

1-2

1.3.Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 2 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		1,0	1,42
Iodine		Active Substance	7553-56-2	231-442-4	0,21	0,298

2.2.Type(s) of formulation of the meta SPC 2

Formulation(s)

AL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements	Harmful to aquatic life with long lasting effects.Safety data sheet available on request.
Precautionary statements	Keep out of reach of children.Avoid release to the environment.Dispose of contents in accordance with local/regional/national/international regulation.Dispose of container in accordance with local/regional/national/international regulation.

4.AUTHORISED USE(S) OF THE META SPC 24.1.Use description

Table 6. Use # 1 – Post-milking manual dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual dipping (RTU)Fill the reservoir with the RTU product and screw the dip cup on top.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 7. Use # 2 – Post-milking automated dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated dipping (RTU)Open a can containing the RTU product and insert the suction tube of the automated dipping-system.Before milking clean teats carefully by automatic procedure or manually.After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air. In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air. Afterwards, the milking system is ready for the next milking event. The whole process is automated.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.2.1.Use-specific instructions for useSee general directions for use.4.2.2.Use-specific risk mitigation measuresSee general directions for use.4.2.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. OF THE META SPC 25.1.Instructions for useThe products must be brought to temperatures above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended.To ensure sufficient contact time, care should be taken that the product is not removed after application. Leave the product on the teats and keep the animals standing for at least five minutes after treatment for post-milking disinfection.5.2.Risk mitigation measuresIn case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentDescription of first aid measuresGeneral: Remove affected person from source of contamination.After inhalation: Remove person to fresh air and keep comfortable for breathing. Get medical attention if any discomfort continues.After skin contact: Rinse with water. Remove contaminated clothing and shoes. Seek medical advice if any skin reaction/or discomfort occurs.After eye contact: Immediately rinse with water (at least 15 minutes). Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if any discomfort continues.After ingestion: Contact poison treatment specialist immediately if symptoms occur and/or in case of mouth contact with large quantities. Do not give fluids or induce vomiting in case of impaired consciousness; place in recovery position and seek medical advice immediately.If medical advice is needed, have product container or label at hand.Environmental emergency measuresPrevent run-off from entering drains, sewers or waterwaysInform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air)Dike to collect larger liquid spillsContain and/or absorb spill with inert material, then place in closed and suitable container for disposal according to regulationsDo not place spilled materials back into the original container5.4.Instructions for safe disposal of the product and its packagingMethod of disposal: Dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.Empty containers are rinsed with plenty of water and disposed to normal or commercial waste.The paper towels used for the cleaning of teats are disposed in the normal rubbish.Product classified as hazardous waste: NoPackaging classified as hazardous waste: NoEWC waste code: EWC: 0706 wastes from the MFSU of fats, grease, soaps, detergents, disinfectants and cosmeticsOther information: When handling waste, consideration should be made to the safety precautions applying to handling of the product. Waste code applies to product remnants in pure form.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageMentioned in the SDS: Keep in original container. Store the product away from direct sunlight in opaque containers. Keep separate from food, feedstuffs, fertilisers and other sensitive material. Store above freezing.Storage temperature: 0 – 30 °CShelf-life: 24 months.6.OTHER INFORMATIONpH range of meta-SPC 2: 4-57.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 27.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	Jopo FilmIO Super DipBarrera Dip
Authorisation number	EU-0019757-0002 1-2
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		1,42
Iodine		Active Substance	7553-56-2	231-442-4	0,298

META SPC 31.META SPC 3 ADMINISTRATIVE INFORMATION1.1.Meta SPC 3 identifier

Identifier

meta-SPC 3

1.2.Suffix to the authorisation number

Number

1-3

1.3.Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 3 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		0,82	0,99
Iodine		Active Substance	7553-56-2	231-442-4	0,172	0,208

2.2.Type(s) of formulation of the meta SPC 3

Formulation(s)

AL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements	Safety data sheet available on request.
Precautionary statements	Keep out of reach of children.

4.AUTHORISED USE(S) OF THE META SPC 34.1.Use description

Table 8. Use # 1 – Post-milking manual dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual dipping (RTU)Fill the reservoir with the RTU product and screw the dip cup on top.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatmentPost-milking application 1-3 times per day (apply after every milking)
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.1.1.Use-specific instructions for useSee general directions for use4.1.2.Use-specific risk mitigation measuresSee general directions for use.4.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.4.2.Use description

Table 9. Use # 2 – Post-milking automated dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated dipping (RTU)Open a can containing the RTU product and insert the suction tube of the automated dipping-system.Before milking clean teats carefully by automatic procedure or manually.After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air. In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air. Afterwards, the milking system is ready for the next milking event. The whole process is automated.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatmentPost-milking application 1-3 times per day (apply after every milking)
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.2.1.Use-specific instructions for useSee general directions for use4.2.2.Use-specific risk mitigation measuresSee general directions for use.4.2.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3. OF THE META SPC 35.1.Instructions for useFill the reservoir with the RTU product and screw the dip cup on top.The products must be brought to temperatures above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommendedTo ensure sufficient contact time, care should be taken that the product is not removed after application. Leave the product on the teats and keep the animals standing for at least five minutes after treatment for post-milking disinfection.5.2.Risk mitigation measuresIn case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentDescription of first aid measuresGeneral: Remove affected person from source of contamination.After inhalation: Remove person to fresh air and keep comfortable for breathing. Get medical attention if any discomfort continues.After skin contact: Rinse with water. Remove contaminated clothing and shoes. Seek medical advice if any skin reaction/or discomfort occurs.After eye contact: Immediately rinse with water (at least 15 minutes). Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if any discomfort continues.After ingestion: Contact poison treatment specialist immediately if symptoms occur and/or in case of mouth contact with large quantities. Do not give fluids or induce vomiting in case of impaired consciousness; place in recovery position and seek medical advice immediately.If medical advice is needed, have product container or label at hand.Environmental emergency measuresPrevent run-off from entering drains, sewers or waterwaysInform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air)Dike to collect larger liquid spillsContain and/or absorb spill with inert material, then place in closed and suitable container for disposal according to regulationsDo not place spilled materials back into the original container5.4.Instructions for safe disposal of the product and its packagingMethod of disposal: Dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.Empty containers are rinsed with plenty of water and disposed to normal or commercial waste.The paper towels used for the cleaning of teats are disposed in the normal rubbish.Product classified as hazardous waste: NoPackaging classified as hazardous waste: NoEWC waste code: EWC: 0706 wastes from the MFSU of fats, grease, soaps, detergents, disinfectants and cosmeticsOther information: When handling waste, consideration should be made to the safety precautions applying to handling of the product. Waste code applies to product remnants in pure form.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageMentioned in the SDS: Keep in original container. Store the product away from direct sunlight in opaque containers. Keep separate from food, feedstuffs, fertilisers and other sensitive material. Store above freezing.Storage temperature: 0 – 30 °CShelf-life: 18 months.6.OTHER INFORMATIONpH range of meta-SPC 3: 4-57.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 37.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	Nova Dip BarriereIO Multi Dip
Authorisation number	EU-0019757-0003 1-3
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		0,82
Iodine		Active Substance	7553-56-2	231-442-4	0,172

META SPC 41.META SPC 4 ADMINISTRATIVE INFORMATION1.1.Meta SPC 4 identifier

Identifier

meta-SPC 4

1.2.Suffix to the authorisation number

Number

1-4

1.3.Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 4 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		0,714	0,99
Iodine		Active Substance	7553-56-2	231-442-4	0,15	0,208

2.2.Type(s) of formulation of the meta SPC 4

Formulation(s)

AL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	Safety data sheet available on request.
Precautionary statements	Keep out of reach of children.

4.AUTHORISED USE(S) OF THE META SPC 44.1.Use description

Table 10. Use # 1 – Post-milking manual dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual dipping (RTU)Fill the reservoir with the RTU product and screw the dip cup on top.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 11. Use # 2 – Post-milking, manual spraying, trigger sprayer (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual spraying, trigger sprayer (RTU)Fill the reservoir with the RTU product and screw the top of the trigger sprayer on it.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, spray the disinfectant on the teats using the trigger sprayer making sure that each teat is covered with the disinfectant. Top up the reservoir with fresh disinfectant as needed. After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.2.1.Use-specific instructions for useSee general directions for use.4.2.2.Use-specific risk mitigation measuresWear protective chemical resistant gloves when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information).4.2.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.4.3.Use description

Table 12. Use # 3 – Post-milking manual spraying using an electronic sprayer (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual spraying, electronic sprayer (RTU)Open a can containing the RTU product and insert the suction tube of the electronic sprayer.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, spray the disinfectant on the teats using the electronic sprayer making sure that each teat is covered with the disinfectant. Replace the empty can by a new can as needed. After disinfection, put the suction tube system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0.5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.3.1.Use-specific instructions for useSee general directions for use.4.3.2.Use-specific risk mitigation measuresWear protective chemical resistant gloves when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information).4.3.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.3.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.3.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.4.4.Use description

Table 13. Use # 4 – Post-milking automated dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated dipping (RTU)Open a can containing the RTU product and insert the suction tube of the automated dipping-system.Before milking clean teats carefully by automatic procedure or manually.After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air. In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air. Afterwards, the milking system is ready for the next milking event. The whole process is automated.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 14. Use # 5 – Post-milking automated spraying by robot (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated spraying by robot (RTU)Open a can containing the RTU product and insert the suction tube of the robotic milking device.The teats are cleaned by robot with automatic brushes. After robotic milking, 2-4 ml of the disinfectant is sprayed automatically onto teats from a cluster arm. Rinsing of the sprayer is automatic.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.5.1.Use-specific instructions for useSee general directions for use.4.5.2.Use-specific risk mitigation measuresSee general directions for use.4.5.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.5.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.5.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4. OF THE META SPC 45.1.Instructions for useFill the reservoir with the RTU product and screw the dip cup on top.The products must be brought to temperatures above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended.To ensure sufficient contact time, care should be taken that the product is not removed after application. Leave the product on the teats and keep the animals standing for at least five minutes after treatment for post-milking disinfection.5.2.Risk mitigation measuresIn case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentDescription of first aid measuresGeneral: Remove affected person from source of contamination.After inhalation: Remove person to fresh air and keep comfortable for breathing. Get medical attention if any discomfort continues.After skin contact: Rinse with water. Remove contaminated clothing and shoes. Seek medical advice if any skin reaction/or discomfort occurs.After eye contact: Immediately rinse with water (at least 15 minutes). Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if any discomfort continues.After ingestion: Contact poison treatment specialist immediately if symptoms occur and/or in case of mouth contact with large quantities. Do not give fluids or induce vomiting in case of impaired consciousness; place in recovery position and seek medical advice immediately.If medical advice is needed, have product container or label at hand.Environmental emergency measuresPrevent run-off from entering drains, sewers or waterwaysInform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air)Dike to collect larger liquid spillsContain and/or absorb spill with inert material, then place in closed and suitable container for disposal according to regulationsDo not place spilled materials back into the original container5.4.Instructions for safe disposal of the product and its packagingMethod of disposal: Dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.Empty containers are rinsed with plenty of water and disposed to normal or commercial waste.The paper towels used for the cleaning of teats are disposed in the normal rubbish.Product classified as hazardous waste: NoPackaging classified as hazardous waste: NoEWC waste code: EWC: 0706 wastes from the MFSU of fats, grease, soaps, detergents, disinfectants and cosmeticsOther information: When handling waste, consideration should be made to the safety precautions applying to handling of the product. Waste code applies to product remnants in pure form.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageMentioned in the SDS: Keep in original container. Store the product away from direct sunlight in opaque containers. Keep separate from food, feedstuffs, fertilisers and other sensitive material. Store above freezing.Storage temperature: 0 – 30 °CShelf-life: 24 months.6.OTHER INFORMATIONpH range of meta-SPC 4: 4-57.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 47.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	Jopo SprayIO SprayBarrera SprayAgro Teat SprayNova Dip Ready for Use
Authorisation number	EU-0019757-0004 1-4
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		0,714
Iodine		Active Substance	7553-56-2	231-442-4	0,15

META SPC 51.META SPC 5 ADMINISTRATIVE INFORMATION1.1.Meta SPC 5 identifier

Identifier

meta-SPC 5

1.2.Suffix to the authorisation number

Number

1-5

1.3.Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 5 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 5

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		1,0	1,46
Iodine		Active Substance	7553-56-2	231-442-4	0,21	0,307

2.2.Type(s) of formulation of the meta SPC 5

Formulation(s)

AL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements	Harmful to aquatic life with long lasting effects.Safety data sheet available on request.
Precautionary statements	Keep out of reach of children.Avoid release to the environment.Dispose of contents in accordance with local/regional/national/international regulation.Dispose of container in accordance with local/regional/national/international regulation.

4.AUTHORISED USE(S) OF THE META SPC 54.1.Use description

Table 15. Use # 1 – Post-milking manual dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual dipping (RTU)Fill the reservoir with the RTU product and screw the dip cup on top.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed.. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 16. Use # 2 – Post-milking, manual spraying, trigger sprayer (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual spraying, trigger sprayer (RTU)Fill the reservoir with the RTU product and screw the top of the trigger sprayer on it.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, spray the disinfectant on the teats using the trigger sprayer making sure that each teat is covered with the disinfectant. Top up the reservoir with fresh disinfectant as needed.After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 17. Use # 3 – Post-milking manual spraying using an electronic sprayer (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual spraying, electronic sprayer (RTU)Open a can containing the RTU product and insert the suction tube of the electronic sprayer.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, spray the disinfectant on the teats using the electronic sprayer making sure that each teat is covered with the disinfectant. Replace the empty can by a new can as needed. After disinfection, put the suction tube system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatmentPost-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 18. Use # 4 – Post-milking automated dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated dipping (RTU)Open a can containing the RTU product and insert the suction tube of the automated dipping-system.Before milking clean teats carefully by automatic procedure or manually.After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air. In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air. Afterwards, the milking system is ready for the next milking event. The whole process is automated.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0.5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 19. Use # 5 – Post-milking automated spraying by robot (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated spraying by robot (RTU)Open a can containing the RTU product and insert the suction tube of the robotic milking device.The teats are cleaned by robot with automatic brushes. After robotic milking, 2-4 ml of the disinfectant is sprayed automatically onto teats from a cluster arm. Rinsing of the sprayer is automatic.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0.5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.5.1.Use-specific instructions for useSee general directions for use.4.5.2.Use-specific risk mitigation measuresSee general directions for use.4.5.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.5.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.5.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5. OF THE META SPC 55.1.Instructions for useFill the reservoir with the RTU product and screw the dip cup on top.The products must be brought to temperatures above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended.To ensure sufficient contact time, care should be taken that the product is not removed after application. Leave the product on the teats and keep the animals standing for at least five minutes after treatment for post-milking disinfection.5.2.Risk mitigation measuresIn case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentDescription of first aid measuresGeneral: Remove affected person from source of contamination.After inhalation: Remove person to fresh air and keep comfortable for breathing. Get medical attention if any discomfort continues.After skin contact: Rinse with water. Remove contaminated clothing and shoes. Seek medical advice if any skin reaction/or discomfort occurs.After eye contact: Immediately rinse with water (at least 15 minutes). Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if any discomfort continues.After ingestion: Contact poison treatment specialist immediately if symptoms occur and/or in case of mouth contact with large quantities. Do not give fluids or induce vomiting in case of impaired consciousness; place in recovery position and seek medical advice immediately.If medical advice is needed, have product container or label at hand.Environmental emergency measuresPrevent run-off from entering drains, sewers or waterwaysInform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air)Dike to collect larger liquid spillsContain and/or absorb spill with inert material, then place in closed and suitable container for disposal according to regulationsDo not place spilled materials back into the original container5.4.Instructions for safe disposal of the product and its packagingMethod of disposal: Dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.Empty containers are rinsed with plenty of water and disposed to normal or commercial waste.The paper towels used for the cleaning of teats are disposed in the normal rubbish.Product classified as hazardous waste: NoPackaging classified as hazardous waste: NoEWC waste code: EWC: 0706 wastes from the MFSU of fats, grease, soaps, detergents, disinfectants and cosmeticsOther information: When handling waste, consideration should be made to the safety precautions applying to handling of the product. Waste code applies to product remnants in pure form.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageMentioned in the SDS: Keep in original container. Store the product away from direct sunlight in opaque containers. Keep separate from food, feedstuffs, fertilisers and other sensitive material. Store above freezing.Storage temperature: 0 – 30 °CShelf-life: 24 months.6.OTHER INFORMATIONpH range of meta-SPC 5: 4-57.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 57.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	Nova Dip Spray 3000IO Spray PlusPV-Plus 3000Tehotippi Soft PlusF 6 Robo V
Authorisation number	EU-0019757-0005 1-5
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		1,46
Iodine		Active Substance	7553-56-2	231-442-4	0,307

META SPC 61.META SPC 6 ADMINISTRATIVE INFORMATION1.1.Meta SPC 6 identifier

Identifier

meta-SPC 6

1.2.Suffix to the authorisation number

Number

1-6

1.3.Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 6 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 6

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		1,0	1,43
Iodine		Active Substance	7553-56-2	231-442-4	0,21	0,3

2.2.Type(s) of formulation of the meta SPC 6

Formulation(s)

EW — Emulsion, oil in water

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements	Harmful to aquatic life with long lasting effects.Safety data sheet available on request.
Precautionary statements	Keep out of reach of children.Avoid release to the environment.Dispose of contents in accordance with local/regional/national/international regulation.Dispose of container in accordance with local/regional/national/international regulation.

4.AUTHORISED USE(S) OF THE META SPC 64.1.Use description

Table 20. Use # 1 – Post-milking manual dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual dipping (RTU)Fill the reservoir with the RTU product and screw the dip cup on top.Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 21. Use # 2 – Post-milking, manual spraying, trigger sprayer (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual spraying, trigger sprayer (RTU)Fill the reservoir with the RTU product and screw the top of the trigger sprayer on it.Clean carefully the teats by wiping with a single service paper towel/cloth before milking. After milking, spray the disinfectant on the teats using the trigger sprayer making sure that each teat is covered with the disinfectant. Top up the reservoir with fresh disinfectant as needed. After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 22. Use # 3 – Post-milking manual spraying using an electronic sprayer (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Manual spraying, electronic sprayer (RTU)Open a can containing the RTU product and insert the suction tube of the electronic sprayer.Clean carefully the teats by wiping with a single service paper towel/cloth before milking. After milking, spray the disinfectant on the teats using the electronic sprayer making sure that each teat is covered with the disinfectant. Replace the empty can by a new can as needed. After disinfection, put the suction tube system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 23. Use # 4 – Post-milking automated dipping (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated dipping (RTU)Open a can containing the RTU product and insert the suction tube of the automated dipping-system.Before milking clean teats carefully by automatic procedure or manually.After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air. In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air. Afterwards, the milking system is ready for the next milking event. The whole process is automated.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

Table 24. Use # 5 – Post-milking automated spraying by robot (RTU)

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorDISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking.
Application method(s)	Automated spraying by robot (RTU)Open a can containing the RTU product and insert the suction tube of the robotic milking device.The teats are cleaned by robot with automatic brushes. After robotic milking, 2-4 ml of the disinfectant is sprayed automatically onto teats from a cluster arm. Rinsing of the sprayer is automatic.
Application rate(s) and frequency	Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment.Post-milking application 1-3 times per day (apply after every milking).
Category(ies) of users	Professional
Pack sizes and packaging material	Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 LPlastic drum, HDPE: 200 LIBC, HDPE: 1000 LOpaque containers.

4.5.1.Use-specific instructions for useSee general directions for use.4.5.2.Use-specific risk mitigation measuresSee general directions for use.4.5.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.5.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.5.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6. OF THE META SPC 65.1.Instructions for useFill the reservoir with the RTU product and screw the dip cup on top.The products must be brought to temperatures above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended.To ensure sufficient contact time, care should be taken that the product is not removed after application. Leave the product on the teats and keep the animals standing for at least five minutes after treatment for post-milking disinfection.5.2.Risk mitigation measuresIn case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentDescription of first aid measuresGeneral: Remove affected person from source of contamination.After inhalation: Remove person to fresh air and keep comfortable for breathing. Get medical attention if any discomfort continues.After skin contact: Rinse with water. Remove contaminated clothing and shoes. Seek medical advice if any skin reaction/or discomfort occurs.After eye contact: Immediately rinse with water (at least 15 minutes). Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if any discomfort continues.After ingestion: Contact poison treatment specialist immediately if symptoms occur and/or in case of mouth contact with large quantities. Do not give fluids or induce vomiting in case of impaired consciousness; place in recovery position and seek medical advice immediately.If medical advice is needed, have product container or label at hand.Environmental emergency measuresPrevent run-off from entering drains, sewers or waterwaysInform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air)Dike to collect larger liquid spillsContain and/or absorb spill with inert material, then place in closed and suitable container for disposal according to regulationsDo not place spilled materials back into the original container5.4.Instructions for safe disposal of the product and its packagingMethod of disposal: Dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.Empty containers are rinsed with plenty of water and disposed to normal or commercial waste.The paper towels used for the cleaning of teats are disposed in the normal rubbish.Product classified as hazardous waste: NoPackaging classified as hazardous waste: NoEWC waste code: EWC: 0706 wastes from the MFSU of fats, grease, soaps, detergents, disinfectants and cosmeticsOther information: When handling waste, consideration should be made to the safety precautions applying to handling of the product. Waste code applies to product remnants in pure form.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageMentioned in the SDS: Keep in original container. Store the product away from direct sunlight in opaque containers. Keep separate from food, feedstuffs, fertilisers and other sensitive material. Store above freezing.Storage temperature: 0 – 30 °CShelf-life: 24 months.6.OTHER INFORMATIONpH range of meta-SPC 6: 4-57.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 67.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	Jopo WintersprayIO WintersprayJodopax RTUBarrera W
Authorisation number	EU-0019757-0006 1-6
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		1,43
Iodine		Active Substance	7553-56-2	231-442-4	0,3

Commission Implementing Regulation (EU) 2019/423 of 13 March 2019 granting a Union authorisation for the biocidal product family ‘Teat disinfectants biocidal product family of Novadan’